The Reset application is designed to help treat abuse of alcohol, cocaine, marijuana and stimulant medications. But the app is not intended for opioid dependence, the FDA said.

Citing the Substance Abuse and Mental Health Services Administration, the FDA said criteria for Substance Use Disorders (SUD) are met when chronic use of these substances causes "significant impairment, such as health problems, disability and failure to meet major responsibilities at work, school or home."

"This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment," said Carlos Peña, Ph.D., director of the FDA's Division of Neurological and Physical Medicine Devices.

The agency said it reviewed a 12-week clinical study involving nearly 400 people. Among those who used the app, 40.3 percent abstained from further alcohol, cocaine, marijuana or stimulant use, compared with 17.6 percent among those who did not use the app.

Approval of the app was given to Pear Therapeutics, based in Boston and San Francisco.